Comparing anticoagulation strategies after brain hemorrhage in patients with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is an open-label, randomized controlled multicenter study designed to evaluate three different strategies for managing patients with a history of intracerebral hemorrhage (ICH) and atrial fibrillation (AF). Participants will be assigned to one of three groups: those receiving direct oral anticoagulation with Apixaban, those undergoing left atrial appendage closure, and those receiving usual care without anticoagulation. The primary outcome will assess the net clinical benefit, which includes major ischemic and hemorrhagic events over a 24-month follow-up period. The results aim to guide clinicians in determining the most effective treatment strategy for preventing future vascular events in this patient population.

Why it matters

Who can join: the full rules

Inclusion criteria

* Adult (older than 18 years old, no upper age limit)
* with a history of paroxysmal, persistent or long-standing non-valvular atrial fibrillation (documented on an electrocardiogram)
* and a CHA2DS2VASc score of 2 or more who have an indication for long-term anticoagulation
* who suffered from a spontaneous intracerebral haemorrhage (while being treated with oral anticoagulants or not) documented with brain CT or MRI
* more than 14 days before randomization (no upper delay limit)
* for whom there is a clinical equipoise regarding the choice of the best preventive strategy to avoid future vascular events.

Exclusion criteria for all treatment groups

* Pre-randomisation modified Rankin score of 4 or 5
* Conditions other than atrial fibrillation for which the patient requires long term anticoagulation (for example prosthetic mechanical heart valve)
* Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage)
* Life expectancy of less than 1 year
* Pregnancy or breastfeeding

Exclusion criteria related to the LAAC only

* Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis)
* Patients older than 85 years
* CHA2DS2VASc score of 2 or 3
* Patient or attending physician are unwilling to undergo/perform intervention for LAAC

Exclusion criteria related to the Direct OAC only

* Chronic renal insufficiency (clearance of creatinine by Cockcroft method \< 30ml/min)
* Body weight lower than 50 kg
* Allergy to apixaban
* Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders)
* Patient or attending physician are unwilling to use of Direct OAC

Where it's running

• Hôpital Roger Salengro, CHU
  Lille, France Recruiting
• Ghicl
  Lomme, France Recruiting
• CH De Tourcoing
  Tourcoing, France Recruiting

Study contacts

• Principal investigator: Charlotte Cordonnier, MD, PhD — University Hospital Lille, Inserm, Univ Lille
• Study coordinator: Charlotte Cordonnier, MD, PhD
• Email: charlotte.cordonnier@chru-lille.fr
• Phone: 3 20 44 68 14

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.